Foot pedal medical irrigation system

ABSTRACT

A foot pedal irrigation system allows a physician or other operating person to control the flow of irrigation fluid to a diagnostic or therapeutic device without using the physician&#39;s hands. The system attaches to one or more bags of irrigation fluid and uses clamps on inlet and output tubing. The system may include a visual drip chamber to monitor fluid flow without applying pressure to a foot pump which is part of the system. When increased irrigation is desired, the physician presses with a foot on the foot pedal pump; one way valves assure the increased one-way flow of fluid from the pump to the diagnostic or therapeutic device.

This application claims the benefit of the filing date under 35 U.S.C. § 119(e) of Provisional U.S. Patent Application Ser. No. 60/491,024, filed on Jul. 30, 2003, which is hereby incorporated by reference in its entirety.

BACKGROUND

Physicians use a variety of instruments to diagnose and treat patients internally, such as endoscopes, ureteroscopes, and hysteroscopes. These instruments typically have an optical system, usually including a light source and an optical fiber or other device for transmitting light, in order to receive visual information as a part of a diagnostic or therapeutic procedure. If the instrument is used for treatment, the optical system may be essential for determining the progress of the treatment, e.g., removal of obstacles or stones from the patient.

The bodily processes of the patient continue, unabated for the most part, during any of these diagnostic or therapeutic procedures. Therefore, one problem with virtually all these systems is the continuing need to clear the field of view because of obstruction by bodily fluids or other interferences during the procedure. Therefore, many such diagnostic or therapeutic instruments have an irrigation channel, for providing a flow of irrigating fluid to the operating field and providing a continual clearing of the transmitting medium used. These channels can provide irrigating fluid, and with a hand pump, can also increase the flow of fluid when desired by the physician. The physician, busy manipulating the diagnostic or therapeutic instrument, can instruct an assistant to increase or decrease the flow of fluid when desired. A pump under electrical or computer control may also be used, but this may unnecessarily complicate the irrigation apparatus.

Of course, this requires the use of an assistant during the procedure, because the physician typically does not have a hand free for use on a hand pump simply for the purpose of regulating the flow of irrigation fluid. Other ways may also be used to control the flow of irrigating fluid, such as by using a mechanical pump under electrical or computer control, but this may unnecessarily complicate the nature of the relatively simple apparatus typically used to provide irrigation.

It would be desirable to put the flow of fluid under the direct control of the physician, and would also be desirable to allow the physician's assistant freedom to assist in aspects of the procedure other than merely controlling the flow of irrigation fluid. What is needed is a better way to provide a controlled flow of fluid to diagnostic and therapeutic instruments under the direct control of the physician or surgeon performing the procedure. This way preferably would not involve an electronic controller or computer, or other complicated equipment requiring maintenance and calibration.

BRIEF SUMMARY

One aspect of the invention is a foot pedal irrigation system, the system comprising a pump body configured for operation during a medical procedure by a foot of a user, and a fluid outlet fitting and a fluid inlet fitting connected to the pump body. The system also comprises at least one check valve connected to the fluid outlet fitting or the fluid inlet fitting.

Another aspect of the invention is a foot pedal irrigation system, the system comprising inlet tubing suitable for attachment of a fluid for use during a medical procedure, a pump body connected to the inlet tubing by an inlet check valve, the pump body comprising a chamber for holding fluid, a lower surface comprising a stiffener plate, and an upper surface configured for use by a foot of a user. The system also comprises outlet tubing connected to the pump body via an outlet check valve.

Another aspect of the invention is a method of making a foot pedal irrigation system suitable for use during a medical procedure. The method comprises forming a valve housing and a pump housing, attaching an inlet check valve and an outlet check valve to the valve housing, adhering the valve housing to the pump housing, and attaching inlet fluid tubing suitable for a medical fluid to the inlet check valve and attaching fluid outlet tubing to the outlet check valve.

Another aspect of the invention is a method of irrigating a medical instrument. The method includes the steps of connecting a source of irrigation fluid to a foot pedal irrigation system, and filling with irrigation fluid a pump body configured for operation during a medical procedure by a foot of a user. The method also includes controlling a flow of irrigation fluid through fluid inlet tubing and fluid outlet tubing to a medical diagnostic or therapeutic instrument.

Other systems, methods, features, and advantages of the invention will be or will become apparent to one skilled in the art upon examination of the following figures and detailed description. All such additional systems, methods, features, and advantages are intended to be included within this description, within the scope of the invention, and protected by the accompanying claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top view of a first embodiment;

FIG. 2 is an elevational cross-sectional view of a portion of the first embodiment; and

FIG. 3 is a diagrammatic view of the use of the embodiment of FIG. 1.

DETAILED DESCRIPTION OF THE DRAWINGS AND THE PRESENTLY PREFERRED EMBODIMENTS

An embodiment of the foot pedal irrigation system is depicted in FIG. 1. The irrigation system includes a foot pedal pump body 10, an inlet valve 11 and an outlet valve 16. Inlet valve 11 is connected via tubing 12 to one or more sources of irrigation fluid, such as bags of liquid saline solution (not shown). The connection may be made by joining tubing 12 to a Y-fitting 13 leading to further tubing and thence to tubing spikes 14 for connection to the irrigation fluid. Slide clamps 15 may be used to begin or halt flow of fluid to the pump body. On the outlet side, outlet valve 16 is connected to outlet tubing 17 and to an outlet connector 18. Flow of fluid may be controlled by a clamp, such as an outlet pinch clamp 19. Inlet valve 11 and outlet valve 16 are preferably one-way valves, allowing flow of fluid in only one direction, that is, flow of fluid from the inlet side into the pump, and flow of fluid from the outlet side out of the pump, as indicated by the arrows in FIG. 1. A drip chamber 12 a may also be installed, preferably on the inlet side, so that medical personnel may visually monitor the flow of fluid into the pump body.

The materials used in the foot pedal irrigation system may be any materials that are compatible with the fluid used for irrigation, and acceptable to the medical community and government regulators. Plastic materials are preferred. The pump body is preferably soft plastic, such as plastisol, a material derived from PVC (polyvinyl chloride). Other materials may also be used, such as polypropylene or softer grades of polyethylene. A user uses the foot pedal irrigation system by applying his or her foot to the top surface of the pump body. The pump body deforms in order to force fluid in the pump body out through the outlet valve. When the user's foot is removed, the pump body then recovers its former shape, in preparation for the next application of the user's foot. Therefore, the pump body material should be sufficiently flexible to deform when pressure is applied. It is also important that the material be able to recover its shape relatively quickly when the pressure is removed. Plastisol that is from about 0.075 inches to about 0.100 inches thick has been found to be satisfactory for these purposes. A thickness of about 0.090 inches is preferred. Other thicknesses and other materials may also be used.

Materials for the other parts of the foot pedal irrigation system may also be made from plastic. The drip chamber and tubing to and from the pump may be PVC, or may be made from any other medically-acceptable material, such as silicone, C-flex (thermoplastic elastomeric material), polypropylene, polyethylene, polyurethane, nylon, or fluorocarbon materials, such as polytetrafluoroethylene. Tubing available from United States Plastic Corp., Lima, Ohio, in several materials and several grades and sold under the brand name of “Tygone tubing” may also be used. Soft tubing, with a Shore A durometer from about 65 to 70 is preferred, especially that with a Shore A 68 value. The Y-fitting may be made from any of a variety of materials, including PVC, ABS (acrylonitrile-butadiene-styrene), polycarbonate and acrylic. The bag spikes, which may be equipped with covers, are preferably made from a rigid plastic that will puncture an irrigation bag filled with irrigation fluid. ABS is preferred, but other plastics may be used, such as polycarbonate or acrylic. The slide clamps and pinch clamps may be made from a variety of plastic materials, including but not limit to, ABS, Delrin®, HDPE, acrylic, polycarbonate, or polypropylene.

One-way or check valves 11, 16 are used to insure that the irrigation fluid flows only one way, i.e., from the irrigation bags through inlet valve 11 and into the pump body, and from the pump body out through outlet valve 16 to the outlet tubing. The fluid then flows to the endoscope or other instrument for which irrigation is desired. The valves may be any suitable valves, but those available from Qosina Corp., Edgewood, N.Y. are preferred. In one preferred embodiment, the external portions of the check valves are manufactured in different colors, such as a blue external portion for the inlet valve and a white external portion for the outlet valve. This color coding provides a quick check both for manufacturing personnel and for operating-room personnel that the foot pedal irrigation system has been properly assembled.

A fitting 18 may be used to connect to an irrigation channel on the endoscope or other instrument that is being irrigated. The fitting may be a male Luer lock attachment or fitting, which may also be made from any suitable plastic material, including, but not limited to, polycarbonate, ABS, HDPE (high density polyethylene), polypropylene, and polystyrene.

The parts may be assembled as shown in FIGS. 1 and 2 using adhesives or other joining methods. Pump body 10 may include a pump housing 10 a and a valve housing 10 b. The pump body may also include a back plate 10 d that is adhered to the pump housing. The plate provides a stiffening function to the pump body, and may also be used to resist skidding or movement when the pump is in use. Plate 10 d is preferably roughly co-extensive with the bottom surface of pump body 10. The plate may be made of a stiff plastic about 0.050 to 0.125 inches thick, such as PVC, HDPE, or ABS, or may be made from a metal, such as steel. {fraction (1/16)}″ (0.0625″) PVC plates have worked well. Plate 10 d preferably has a roughened or non-skid surface 10 e suitable for placement on a floor or mat, so that the pump does not skid when the user applies pressure with a foot. The non-skid surface may be similar to sandpaper in having an abrasive, non-slippery texture that prevents easy movement across a floor or other surface.

Inlet and outlet valves 11, 16 may be adhered to the valve housing 10 b with PVC cement. Valve housing 10 b is then adhered to the pump housing 10 a, also with PVC cement. Outlet tubing 17 and fitting 18 may also be secured with PVC cement. Other connections may be cemented or may be pressed on tightly to avoid leaks. Other medically acceptable adhesives may also be used, and other methods of assembly may also be used. For instance, ultrasonic welding is known to provide quick, leak-free connections between parts.

Pump body 10 may have a generally rectangular footprint as shown in FIG. 1, with dimensions of about five inches long by about three inches wide, and with an overall fluid capacity of from about 25-500 ml, preferably from about 150-350 ml. While the rectangular shape is preferred, other shapes may instead be used, such as a rounded body shape, an elliptical shape, or any other convenient shape. The pump body is preferably angled, from about 20 degrees to about 40 degrees, as shown in FIG. 2, to accept a shoe of a user at a slight angle. The pump body may have a portion 10 c on its top that is not angled but extends horizontally.

To use the irrigation system, a user spikes a suspended irrigation bag with a spike 14. Connectors may instead be used on the bag and on the tubing. Suspending the irrigation bag several feet in the air provides enough head to flow the fluid through tubing 12 and valve 11, into the pump and out of pump 10 and valve 16, through outlet tubing 17 and through the connector 18 to the ureteroscope or endoscope that requires irrigation. The flow of fluid may be controlled using clamps 15, 19 for a desired flow rate.

When a user desires a greater flow rate, or surge of fluid, the user applies pressure to the pump body 10 through his or her foot, and may also loosen or remove outlet clamp 19. When pressure is applied, fluid in pump body 10 is forced through outlet valve 16, outlet tubing 17 and fitting 18, to the endoscope or other application. Fluid cannot flow through inlet valve 11 because it is a check valve or one-way valve allowing fluid only to enter the pump body. Of course, while pressure is applied to the pump body, fluid cannot enter the pump body through inlet valve 11 because the pressure inside the pump will be greater than the several feet of head provided by the suspended bag of irrigation fluid. When the user removes his or her foot and the pressure on the pump is relieved, fluid can then enter the pump from the inlet line, replenishing the fluid in the pump and allowing resumption of a normal, lower flow rate of irrigation fluid.

FIG. 3 depicts a diagrammatic view of the use of a foot pedal irrigation system 20 according to the present invention. The foot pedal irrigation system 20 is connected to at least one bag 21 of saline or other irrigation solution with spike 14. The system is connected via connector 18 to a mating connector of a diagnostic or therapeutic instrument 22. Normal fluid flow is adjusted using clamps 15 on inlet tubing 12 and clamp 19 on outlet tubing 17. The flow of fluid may be monitored with a vertical drip chamber 12 a. A physician or other operating personnel may then adjust the flow of fluid by pressing on pump body 10 with a foot to increase the flow of irrigation fluid, or may step off to decrease the flow. In this way, the flow of irrigation fluid, and the control of the visual field, may be under the direct control of the physician, if he or she desires, without having to go through an assistant, by merely pressing with a foot or removing pressure by ceasing to press with the foot. This allows the physician to use his or her hands as desired, such as operating a diagnostic or therapeutic instrument, such as a hysteroscope, an endoscope, a ureteroscope, and so forth. This allows the physician more control in real time without having to go through the assistant, thus making for a faster response from the irrigation system. At the same time, the user's hands are free for other uses.

It is intended that the foregoing detailed description be regarded as illustrative rather than limiting. While this invention has been shown and described in connection with the preferred embodiments, it is apparent that certain changes and modifications, in addition to those mentioned above, may be made from the basic features of this invention. As an example, the fluid inlet and outlet check valves have been described as colored differently to facilitate connections in the operating suite. Coloring portions of the valve body or pump body near the inlet and outlet portions would be an insubstantial difference from color-coding the check valves themselves.

In another example, the invention has been described as a foot pedal irrigation system, and embodiments of the invention have been characterized as operated by a foot of a user. The foot pedal irrigation system, and the pump body, may be elevated, as by placing on a chair or stool, and operated by a knee of a user. The pump may also be squeezed and operated by using the hand or hands of an operator, though this mode of operation is not as convenient as using a foot. All these methods of use are meant to be included within the scope of the claims.

For a further example, the pump body has been described as manufactured with an upward angle to accommodate the foot of a user. The pump body may also be made flat, and would still work for its intended purpose, albeit not as conveniently as with the angled surface, so long as a foot of a user can bring pressure to bear. The pump body has been described as roughly rectangular in its footprint; other configurations and footprints, however, will also work, such as square, round, elliptical or irregular configurations. A rectangular configuration is more easily tooled and manufactured. In addition, the various volumes and dimensions needed to design the pump are more easily calculated with known, linear shapes, rather than other shapes, which may be used instead.

Accordingly, it is the intention of the applicants to protect all variations and modifications within the valid scope of the present invention. It is intended that the scope and spirit of the invention be defined by the following claims, including all equivalents. 

1. A foot pedal irrigation system, comprising: a pump body configured for operation during a medical procedure by a foot of a user; a fluid outlet fitting and a fluid inlet fitting connected to the pump body; and at least one check valve connected to the fluid outlet fitting or the fluid inlet fitting.
 2. The foot pedal irrigation system of claim 1, further comprising fluid inlet tubing or fluid outlet tubing.
 3. The foot pedal irrigation system of claim 1, wherein the fluid inlet and fluid outlet tubing is selected from the group consisting of medical tubing, silicone tubing, plastic tubing, elastomeric tubing, polypropylene tubing, polyethylene tubing, fluorocarbon tubing, polystyrene tubing, polyurethane tubing, nylon tubing and PVC tubing.
 4. The foot pedal irrigation system of claim 2, further comprising a clamp on the fluid inlet tubing or fluid outlet tubing.
 5. The foot pedal irrigation system of claim 1, wherein the pump body further comprises a back plate.
 6. The foot pedal irrigation system of claim 2, wherein the fluid outlet tubing further comprises a fitting for connecting to a diagnostic or therapeutic instrument.
 7. The foot pedal irrigation system of claim 2, further comprising a drip chamber connected to the fluid inlet tubing.
 8. The foot pedal irrigation system of claim 1, wherein the at least one check valve is color-coded for inlet and outlet.
 9. The foot pedal irrigation system of claim 2, wherein the fluid inlet tubing further comprises at least one bag spike or connector.
 10. The foot pedal irrigation system of claim 1, wherein the pump body comprises a chamber for holding fluid.
 11. A foot pedal irrigation system, comprising: inlet tubing suitable for attachment of a fluid for use during a medical procedure; a pump body connected to the inlet tubing by an inlet check valve, the pump body comprising a chamber for holding fluid, a lower surface comprising a stiffener plate, and an upper surface configured for use by a foot of a user; and outlet tubing connected to the pump body via an outlet check valve.
 12. The foot pedal irrigation system of claim 11, wherein the outlet check valve is colored differently from the inlet check valve.
 13. The foot pedal irrigation system of claim 11, further comprising at least one tubing clamp.
 14. The foot pedal irrigation system of claim 11, wherein the pump body comprises a valve housing and a pump housing.
 15. The foot pedal irrigation system of claim 11, wherein the pump body holds from about 25 to about 500 ml of liquid.
 16. A method of making a foot pedal irrigation system suitable for use during a medical procedure, the method comprising: forming a valve housing and a pump housing; attaching an inlet check valve and an outlet check valve to the valve housing; adhering the valve housing to the pump housing; and attaching inlet fluid tubing suitable for a medical fluid to the inlet check valve and attaching fluid outlet tubing to the outlet check valve.
 17. The method of claim 16, further comprising attaching a back plate to the pump housing.
 18. The method of claim 16, further comprising color coding an inlet portion of the foot pedal irrigation system a first color and color coding an outlet portion of the foot pedal irrigation system a second color.
 19. The method of claim 16, further comprising installing a clamp on at least one of the fluid inlet tubing and fluid outlet tubing.
 20. The method of claim 16, further comprising installing a drip chamber to the fluid inlet tubing.
 21. A method of irrigating a medical instrument, the method comprising: connecting a source of irrigation liquid to the foot pedal irrigation system of claim 1; filling a pump body with irrigation liquid; and controlling a flow of irrigation liquid through fluid inlet tubing and fluid outlet tubing to a medical diagnostic or therapeutic instrument.
 22. The method of claim 21, further comprising squeezing the pump body. 